Pumarix
pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or nurse.
This vaccine has been prescribed for you only. Do not pass it on to others.
If you get any side effects, talk to your doctor. This includes any possible side effects not listed
in this leaflet.
What Pumarix is and what it is used for
What you need to know before you are given Pumarix
How Pumarix is given
Possible side effects
How to store Pumarix
Contents of the pack and other information
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Pumarix is a vaccine for use in adults from 18 years old to prevent pandemic flu (influenza).
Pandemic flu is a type of influenza that happens at intervals that vary from less than 10 years to many decades. It spreads rapidly around the world. The signs of pandemic flu are similar to those of ordinary flu but may be more serious.
When a person is given the vaccine, the body’s natural defence system (immune system) produces its
own protection (antibodies) against the disease. None of the ingredients in the vaccine can cause flu. As with all vaccines, Pumarix may not fully protect all persons who are vaccinated.
if you have previously had a sudden life-threatening allergic reaction to any ingredient of this vaccine (listed in section 6) or to anything else that may be present in very small amounts, such as: egg and chicken protein, ovalbumin, formaldehyde or sodium deoxycholate.
Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling
of the face or tongue.
However, in a pandemic situation, you may still be given the vaccine. This is as long as medical treatment is available straight away, in case you have an allergic reaction.
Do not have Pumarix if any of the above apply to you.
If you are not sure, talk to your doctor or nurse before having this vaccine.
Talk to your doctor or nurse before you are given Pumarix:
if you have had any allergic reaction other than a sudden life-threatening allergic reaction to any ingredient contained in this vaccine (listed in section 6) or to thiomersal, to egg and chicken protein, ovalbumin, formaldehyde or to sodium deoxycholate.
if you have a serious infection with a high temperature (over 38°C). If this applies to you then your vaccination will usually be postponed until you are feeling better. A minor infection such as a cold should not be a problem, but your doctor will advise whether you could still be vaccinated with Pumarix.
if you have problems with your immune system, since your response to the vaccine may then be poor.
if you are having a blood test to look for evidence of infection with certain viruses. In the first few weeks after vaccination with Pumarix the results of these tests may not be correct. Tell the doctor requesting these tests that you have recently been given Pumarix.
if you have a bleeding problem or you bruise easily.
If any of the above apply to you (or you are not sure), talk to your doctor or nurse before having Pumarix. This is because the vaccination may not be recommended, or may need to be delayed.
Fainting can occur following, or even before, any needle injection. Therefore tell the doctor or nurse if you fainted with a previous injection.
If your child receives the vaccine, you should be aware that the side effects may be more intense after
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the second dose, especially temperature over 38°C. Therefore monitoring of temperature and measures to lower the temperature (such as giving paracetamol or other medicines that lower fever) after each dose are recommended.
Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines or have recently received any other vaccine.
In particular, please tell your doctor or nurse if you are having any treatments (such as corticosteroid treatments or chemotherapy for cancer) that affect the immune system. Pumarix can still be given but your response to the vaccine may be poor.
Pumarix is not intended to be given at the same time as some other vaccines. However, if this needs to happen, the other vaccine will be injected into the other arm. Any side effects that happen may be more serious.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask
your doctor for advice before you receive this vaccine.
Some effects listed in Section 4 “Possible side effects” may affect your ability to drive or use tools or
machines. It is best to see how Pumarix affects you before you try these activities.
Pumarix contains thiomersal as a preservative and it is possible that you may experience an allergic reaction. Tell your doctor if you have any known allergies.
Pumarix contains less than 1 mmol sodium (23 mg) and less than 1 mmol of potassium (39 mg) per
dose. It is essentially sodium- and potassium-free.
Adults from 18 years onwards: you will receive two doses of Pumarix. The second dose should be given after an interval of at least three weeks after the first dose.
Adults from 18 years onwards: you will receive one dose of Pumarix.
There is limited information available on the use of vaccine very similar to Pumarix (but manufactured in a different facility) to children aged from 3-9 years who received either two adult doses or two half
adult doses given three weeks apart. There is no information available on use in children aged less than 3 years or aged from 10-17 years.
Your doctor or nurse will give you Pumarix.
They will give Pumarix as an injection into a muscle
This will usually be in the upper arm.
If you have any further questions on the use of this vaccine, ask your doctor or nurse.
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Like all medicines, this vaccine can cause side effects, although not everybody gets them.
Allergic reactions which may cause you to have dangerously low blood pressure. If this is not treated
it may lead to shock. Your doctors know that this might happen and will have emergency treatment ready to use.
Pain where the injection was given
Headache
Feeling tired
Aching muscles, joint pain
Redness and swelling where the injection was given
Fever
Sweating
Shivering
Diarrhoea, feeling sick
Reactions where the injection was given such as bruising, a hard lump, itching, warmth
Swollen glands in your neck
Feeling dizzy
Generally feeling unwell
Unusual weakness
Being sick, stomach pain, acid indigestion
Not being able to sleep
Tingling or numbness of the hands or feet
Shortness of breath
Pain in the chest
Itching, rash
Pain in the back or neck, stiff muscles, muscle spasms, pain in your leg or hand
When a dose of 0.5 ml of a similar vaccine was given to children aged 3-9 years, fever occurred more often than when half of this dose (0.25 ml of vaccine) was given. Also fever occurred more often in children aged 6-9 years compared to the children aged 3-5 years. There was no increase after the second dose whether the children received half of the adult or the adult dose, except for some side effects which were higher after the second dose, particularly for rates of fever in < 6 years old children.
In other clinical studies where children 6 months to 17 years received a similar vaccine containing A/Indonesia/05/2005, increases in the frequency of some side effects (including injection site pain, redness and fever) were seen after the second dose in children aged less than 6 years.
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The side effects listed below have happened with H1N1 AS03-containing vaccines. They may also happen with Pumarix. If any of the side effects below occur, please tell your doctor or nurse immediately:
Allergic reactions leading to a dangerously low blood pressure. If this is not treated, it may lead to shock. Your doctors will know that this might happen and will have emergency treatment ready to use
Fits
Generalised skin reactions including urticaria (hives)
The side effects listed below have happened in the days or weeks after vaccination with vaccines given routinely every year to prevent flu. They may also happen with Pumarix. If any of the side effects below occur, please tell your doctor or nurse immediately:
Serious stabbing or throbbing pain along one or more of your nerves
Low blood platelet count. This can cause bleeding or bruising.
Inflammation of your blood vessels (vasculitis). This can cause skin rashes, joint pain and kidney problems
Problems with your brain and nerves such as inflammation of the central nervous system (encephalomyelitis), inflammation of nerves (neuritis) or a type of paralysis known as ‘Guillain- Barré Syndrome’.
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet.
Keep this vaccine out of the sight and reach of children.
Do not use the suspension and the emulsion after the expiry date which is stated on the carton. The
expiry date refers to the last day of that month.
Store in a refrigerator (2°C to 8°C).
Store in the original package in order to protect from light. Do not freeze.
After mixing, use the vaccine within 24 hours and do not store above 30°C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Split influenza virus, inactivated, containing antigen* equivalent to:
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A/H5N1/Indonesia/5/2005 like strain used (PR8-IBCDC-RG2)3.75 micrograms** per 0.5 ml dose
*propagated in eggs
**expressed in microgram haemagglutinin
This vaccine complies with the WHO recommendation and EU decision for the pandemic.
The vaccine contains an ‘adjuvant’ AS03. This adjuvant contains squalene (10.69 milligrams),
DL-α-tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams). Adjuvants are used to improve the body’s response to the vaccine.
The other ingredients are: thiomersal, sodium chloride, disodium hydrogen phosphate,
potassium dihydrogen phosphate, potassium chloride, water for injections
The suspension is a translucent to off white opalescent suspension, which may sediment slightly. The emulsion is a whitish homogeneous liquid.
Before the vaccine is given, the two parts will be mixed together. The mixed vaccine is a whitish emulsion.
One pack of Pumarix consists of:
one pack containing 50 vials of 2.5 ml suspension (antigen)
two packs containing 25 vials of 2.5 ml emulsion (adjuvant) Marketing Authorisation Holder and Manufacturer GlaxoSmithKline Biologicals s.a.
Rue de l’Institut 89 B-1330 Rixensart Belgium
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
GlaxoSmithKline (Malta) Ltd
Tel: + 356 21 238131
GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00
GlaxoSmithKline GmbH & Co. KG
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Tel: + 49 (0)89 360448701
GlaxoSmithKline Eesti OÜ Tel: +372 667 6900
GlaxoSmithKline Pharma GmbH. Tel: + 43 1 970 75-0
GlaxoSmithKline A.E.B.E
Tηλ: + 30 210 68 82 100
GSK Commercial Sp. z o.o.
Tel.: + 48 (22) 576 9000
GlaxoSmithKline - Produtos Farmacêuticos, Lda.
Tel: + 351 21 412 95 00
Laboratoire GlaxoSmithKline Tél: + 33 (0) 1 39 17 84 44
GlaxoSmithKline (GSK) SRL Tel: +40 (0)21 3028 208
GlaxoSmithKline (Ireland) Ltd
Tel: + 353 (0)1 4955000
GlaxoSmithKline S.p.A.
Tel:+ 39 04 59 21 81 11
GlaxoSmithKline (Cyprus) Ltd
Τηλ: + 357 22 39 70 00
GlaxoSmithKline Latvia SIA
Tel: + 371 67312687
GlaxoSmithKline UK
Tel: + 44 (0)808 100 9997
GlaxoSmithKline Lietuva UAB
Tel: +370 5 264 90 00
Medicinal product no longer authorised
This medicine has been authorised under ’exceptional circumstances’.
This means that for scientific reasons it has been impossible to get complete information on this
medicine.
The European Medicines Agency will review any new information on this medicine every year and this leaflet will be updated as necessary.
The following information is intended for healthcare professionals only: Pumarix consists of two containers:
Suspension: multidose vial containing the antigen, Emulsion: multidose vial containing the adjuvant.
Prior to administration, the two components should be mixed. Instructions for mixing and administration of the vaccine:
Before mixing the two components, the emulsion (adjuvant) and suspension (antigen) should be brought to room temperature (allow a minimum of 15 minutes). Whitish sediments may be observed in the suspension vial; these sediments are part of the normal physical appearance of the suspension. The emulsion presents as a whitish appearance.
Each vial should be shaken and inspected visually for any foreign particulate matter (other than the white sediments described above) and/or abnormal physical appearance. In the event of either being observed (including rubber particles from the stopper), discard the vaccine.
The vaccine is mixed by withdrawing the entire contents of the vial containing the adjuvant by means of a 5 ml syringe and by adding it to the vial containing the antigen. It is recommended to equip the syringe with a 23-G needle. However, in the case this needle size would not be available, a 21-G needle might be used. The vial containing the adjuvant should be maintained in upside down position to facilitate the withdrawal of the full content.
After the addition of the adjuvant to the antigen, the mixture should be well shaken. The mixed
vaccine is a whitish emulsion. In the event of other variation being observed, discard the vaccine.
The volume of the Pumarix vial after mixing is at least 5 ml. The vaccine should be
administered in accordance with the recommended posology (see section 3. “How Pumarix is given”).
The vial should be shaken prior to each administration and inspected visually for any foreign particulate matter and/or abnormal physical appearance. In the event of either being observed (including rubber particles from the stopper), discard the vaccine.
Each vaccine dose of 0.5 ml is withdrawn into a 1 ml syringe for injection and administered intramuscularly. It is recommended to equip the syringe with a needle not larger than 23-G.
After mixing, use the vaccine within 24 hours. The mixed vaccine can either be stored in a refrigerator (2°C – 8°C) or at room temperature (25°C – 30°C). If the mixed vaccine is stored in a refrigerator, it should be brought to room temperature (allow a minimum of 15 minutes)
before each withdrawal.
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The vaccine should not be administered intravascularly.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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Taking into account the PRAC Assessment Report on the PSUR for Pumarix, the scientific conclusions of the PRAC are as follows:
In relation to the identified risk of fever in children (<6 years), the PRAC does not agree with the MAH that the EU SmPC contains appropriate information on this safety concern. As an identified risk, an appropriate warning should be included in section 4.4. Moreover section 4.8 should be revised to reflect reactogenicity data from the three paediatric studies D-Pan H5N1-009, -013 and 032.
Therefore, in view of the available data regarding fever in children, the PRAC considered that changes to the product information were warranted.
The CHMP agrees with the scientific conclusions made by the PRAC.
On the basis of the scientific conclusions for Pumarix, the CHMP is of the opinion that the benefit- risk balance of the medicinal product containing the active substance purified antigen fractions of inactivated split virion A/Indonesia/05/2005 (H5N1)/PR8-IBCDC-RG2 is favourable subject to the proposed changes to the product information.
Medicinal product no longer authorised
The CHMP recommends that the terms of the Marketing Authorisation should be varied.